UMIN-CTR Clinical Trial

Basic information
Public title	A multicenter phase II trial of everolimus for unresectable pancreatic neuroendocrine carcinoma refractory or intolerant to platinum-based regimen
Acronym	NECTOR
Scientific Title	A multicenter phase II trial of everolimus for unresectable pancreatic neuroendocrine carcinoma refractory or intolerant to platinum-based regimen
Scientific Title:Acronym	NECTOR
Region	Japan

Condition
Condition	Unresectable pancreatic neuroendocrine carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety in patients with unresectable pancreatic neuroendocrine carcinoma refractory or intolerant to platinum-based regimen
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Progression free survival
Key secondary outcomes	Overall survival, time to treatment failure, response rate, disease control rate, adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Everolimus 10mg once daily
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Pathologically confirmed pancreatic neuroendocrine carcinoma 2) No indication for surgical resection 3) 20 years of age or over 4) ECOG performance status 0-2 5) Refractory or intolerant to platinum-based regimen 6) Having evaluable lesion by CT 7) No previous chemotherapy within 3 weeks 8) Adequate organ function 9) Written informed consent
Key exclusion criteria	1) NET G1 or G2 by WHO 2010 criteria 2) Interstitial pneumonia or plumonary fibrosis 3) Metastasis to the central nervous system 4) Concomitant malignancy within 3 years 5) Active infection (exept for hepatitis B or C viral infection) 6) Active gastrointestinal ulcer 7) Severe or uncontrollable complications, such as cardiovascular impairment, infection, diabetes mellitus, and pulmonary disease 8) Severe mental disorder 9) Continuous administration of steroid or immunosuppressant 10) Prior treatment of mTOR inhibitor 11) Pregnant or lactating women and women of childbearing age who were not using effective contraception 12) Patients who was judged to be inappropriate for this study by each investigators
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masafumi Ikeda
Organization	National Cancer Center Hospital East
Division name	Department of Hepatobiliary and Pancreatic Oncology
Zip code
Address	6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, JAPAN
TEL	+81-4-7133-1111
Email	masikeda@east.ncc.go.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroyuki Okuyama
Organization	National Cancer Center Hospital East
Division name	Department of Hepatobiliary and Pancreatic Oncology
Zip code
Address	6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, JAPAN
TEL	+81-4-7133-1111
Homepage URL
Email	hokuyama@east.ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital East
Institute
Department

Funding Source
Organization	Cancer Fundation
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions

Institutions

愛知県がんセンター中央病院（愛知県），石川県立中央病院（石川県），大阪府立成人病センター（大阪府），岡山大学（岡山県），香川大学（香川県），神奈川県立がんセンター（神奈川県），金沢大学（石川県），がん研究会有明病院（東京都），関西医科大学（大阪府），北里大学東病院（神奈川県），九州大学（福岡県），京都府立医科大学（京都府），杏林大学（東京都），神戸大学（兵庫県），国立がん研究センター中央病院（東京都），国立がん研究センター東病院（千葉県），国立国際医療研究センター（東京都），大阪医療センター（大阪府），九州がんセンター（福岡県），四国がんセンター（愛媛県），埼玉県立がんセンター（埼玉県），札幌医科大学（北海道），静岡県立静岡がんセンター（静岡県），自治医科大学（栃木県），千葉大学（千葉県），手稲渓仁会病院（北海道），東海大学（神奈川県），東京慈恵会医科大学（東京都），東京慈恵会医科大学附属柏病院（千葉県），東京大学（東京都），富山大学（富山県），名古屋市立西部医療センター（愛知県），宮崎大学（宮崎県），横浜市立大学附属市民総合医療センター（神奈川県）

Other administrative information
Date of disclosure of the study information	2014 Year 01 Month 06 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 26 Day
Date of IRB	2013 Year 12 Month 04 Day
Anticipated trial start date	2014 Year 01 Month 06 Day
Last follow-up date	2019 Year 01 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 01 Month 04 Day
Last modified on	2020 Year 12 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014867